A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression
1 other identifier
interventional
555
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2026
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
January 21, 2026
December 1, 2025
3.5 years
December 3, 2025
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (assessed by the BIRC)
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.
24 months
Secondary Outcomes (9)
Overall Survival
up to 5 years
Progression-Free Survival (assessed by the investigator)
24 months
Objective Response Rate (assessed by the BIRC and investigators)
24 months
Disease Control Rate (assessed by the BIRC and investigators)
24 months
Duration of Response (assessed by the BIRC and investigators)
24 months
- +4 more secondary outcomes
Study Arms (2)
Disitamab Vedotin Combined with Trastuzumab and Tislelizumab
EXPERIMENTALParticipants will receive Disitamab Vedotin, Trastuzumab and Tislelizumab until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first).
Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab
ACTIVE COMPARATORParticipants will receive CAPOX, Trastuzumab and Trastuzumab. Only subjects whose PD-L1 expression is confirmed as CPS ≥1 by the central laboratory will receive pembrolizumab. Treatment will continue until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first).
Interventions
Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;
Tislelizumab: 200 mg, IV, D1, Q3W
Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;
Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;
Pembrolizumab: 200mg, IV, D1, Q3W
Eligibility Criteria
You may qualify if:
- Voluntarily consent to participate in the study and sign the informed consent form
- Expected survival period \>12 weeks
- ECOG Performance Status 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
- HER2-high expression
- At least one assessable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
- Able to understand the study requirements and willing to comply with the study and follow-up procedures
You may not qualify if:
- Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
- Peripheral neuropathy \> Grade 1
- Tumor lesions with a tendency to bleed
- Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
- Bone metastases with a risk of paraplegia
- Past or current interstitial lung disease, or severely impaired lung function
- Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, BJ-Beijing, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2025
First Posted
January 2, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
December 31, 2030
Last Updated
January 21, 2026
Record last verified: 2025-12